Compliance Guidance for Researchers

The following material is adapted from the book ORI Introduction to the Responsible Conduct of Research by Nicholas H. Steneck, published by the DHHS Office of Research Integrity. It is intended to offer additional general guidance to researchers on issues of importance in the compliance area.

Collaborative Research

Researchers increasingly collaborate with colleagues who have the expertise and/or resources needed to carry out a particular project. Collaborations can be as simple as one researcher sharing reagents or techniques with another researcher. They can be as complex as multicentered clinical trials that involve academic research centers, private hospitals, and for-profit companies studying thousands of patients in different states or even countries.

Any project that has more than one person working on it requires some collaboration, i.e., working together. In most projects, however, one person, commonly called the “principal investigator,” or PI, is in charge. Others work under the PI’s direction. In “collaborative” efforts, however, groups of researchers work on a common project as more or less equal partners.

In collaborative projects, researchers continue to share the common responsibilities for the elements of Responsible Conduct of Research, but they assume some additional responsibilities stemming from collaborative relationships. These additional responsibilities arise from the added burdens of:

Increasingly complex roles and relationships

Common, but not necessarily identical, interests

Management requirements

Cultural differences

These are inherent in any large project but especially in collaborative projects. Special attention to these added burdens can help keep collaborative projects running smoothly.

Data Acquisition, Management, Sharing, and Ownership

Researchers spend much of their time collecting data. Data are used to confirm or reject hypotheses, to identify new areas of investigation, to guide the development of new investigative techniques, and more. We launch space probes to collect data that help us understand the origins of the universe and use gene databases as tools for understanding and curing disease. Science as we know and practice it today cannot exist without data.

Data-management practices are becoming increasingly complex and should be addressed before any data are col­lected by taking into consideration four important issues:

Ownership

Collection

Storage

Sharing

The integrity of data and, by implication, the usefulness of the research it supports, depends on careful attention to detail, from initial planning through final publication.

Mentor/Trainee Responsibilities

While conducting investigations, researchers often assume the added role of mentors to trainees.* The mentor-trainee relationship is complex and brings into play potential conflicts. How much time – training time for the mentor, research time for the trainee – should each devote to the other? Who gets credit for ideas that take shape during the course of a shared experiment? Who owns the results? When does a trainee become an independent researcher?

The essential elements of a productive mentor-trainee relationship are difficult to codify into rules or guidelines, leaving most of the decisions about responsible mentoring to the individuals involved. Common sense suggests that good mentoring should begin with:

A clear understanding of mutual responsibilities

A commitment to maintain a productive and supportive research environment

Proper supervision and review

An understanding that the main purpose of the relationship is to prepare trainees to become successful researchers

Understandings and agreements, however, will count for little if they are not backed up by firm commitments to make a relationship work.

Knowing the importance of personal commitments, researchers should carefully consider what responsibilities they have to trainees before they take on the essential task of training new researchers. Trainees, in turn, should be aware of their responsibilities to mentors before accepting a position in a laboratory or program.

*The term "trainee" is used herein to refer to anyone learning to be a researcher under an established researcher’s supervision. This includes graduate students and post-doctoral fellows but may also include undergraduate and high school students working on research projects or junior research faculty, research scientists, and research staff.

Peer Review

Peer review — evaluation by colleagues with similar knowledge and experience — is an essential component of research and the self-regulation of professions. The average person does not have the knowledge and experience needed to assess the quality and importance of research. Peers do. Therefore, many important decisions about research depend on advice from peers, including:

Which projects to fund (grant reviews)

Which research findings to publish (manuscript reviews)

Which scholars to hire and promote (personnel reviews)

Which research is reliable (literature reviews and expert testimony)

The quality of the decisions made in each case depends heavily on the quality of peer review.

Peer review can make or break professional careers and directly influence public policy. The fate of entire research programs, health initiatives, or environmental and safety regulations can rest on peer assessment of proposed or completed research projects. For peer review to work, it must be:

Timely

Thorough

Constructive

Free from personal bias

Respectful of the need for confidentiality

Researchers who serve as peer reviewers should be mindful of the public as well as the professional consequences of their evaluations and exercise special care when making these evaluations.

Recommended Additional Reading on Peer Review:

Publication Practices and Responsible Authorship

Researchers share the results of their works with colleagues and the public in a variety of ways. Early results are usually shared during laboratory meetings, in seminars, and at professional meetings. Final results are usually communicated to others through scholarly articles and books. Public communication takes place through press releases, public announcements, newspaper articles, and public testimony. Some of these ways of communicating research results (i.e., of publication) are well structured and controlled; others are informal and have few controls.

Whether structured or informal, controlled or free-ranging, responsible publication in research should ideally meet some minimum standards. All forms of publication should present:

A full and fair description of the work undertaken

An accurate report of the results

An honest and open assessment of the findings

The names that appear at the beginning of a paper serve one important purpose. They let others know who conducted the research and should get credit for it. It is important to know who conducted the research in case there are questions about methods, data, and the interpretation of results. Likewise, the credit derived from publications is used to determine a researcher's worth. Researchers are valued and promoted in accordance with the quality and quantity of their research publications. Consequently, the authors listed on papers should fairly and accurate represent the person or persons responsible for the work in question.